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Table 2 Efficacy results (ITT population)

From: Phase II study of lapatinib in combination with vinorelbine, as first or second-line therapy in women with HER2 overexpressing metastatic breast cancer

Characteristic Lapatinib + vinorelbine (N=44)
Investigator assessed Overall Response Rate (ORR)
 Overall response rate (CR+PR), n (%) 18 (41)
 (95% CI) (26.4, 55.4)
Best response, n (%)  
 Complete response (CR) 4 (9)
 Partial response (PR) 14 (32)
 Stable disease (SD) 14 (32)
 Progressive disease (PD) 5 (11)
 Unknown 7 (16)
Investigator assessed Progression-Free Survival (PFS)
Patients, n (%)  
 Progressed or died due to any cause * 29 (66)
 Censored, follow-up ended 15 (34)
Kaplan-Meier estimate for PFS (weeks)  
 Median (95% CI) 24.1 (16.9, 36.7)
Time to response (TTR)
Patients, n (%) 18 (100)
Kaplan-Meier estimate for TTR (weeks)  
 Median (95% CI) 7.5 (7.1, 8.1)
Duration of Response (DoR)
Patients, n (%) 18 (100)
 Progressed or died due to any cause 13 (72)
 Censored, follow-up ended 5 (28)
Kaplan-Meier estimate for DoR (weeks)  
 Median (95% CI) 32.0 (18.0, 42.3)
  1. *All deaths were due to breast cancer, therefore progression-free survival and time to progression (TTP) were the same.
  2. CI, confidence interval.